FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
BSE
Analyzer, Gas, Helium, Gaseous-Phase
2
Product Code
BSI
Algesimeter, Powered
2
Product Code
BTY
Calculator, Predicted Values, Pulmonary Function
2
Product Code
K
22
3629
SpiroSphere, SpiroSphereECG, CardioSphere
2
Cleared 510(K)
K
23
1561
Pulmonary Function Tester, Model: A9
2
Cleared 510(K)
K
22
2982
Virtus Metabolic Monitor
2
Cleared 510(K)
K
22
1030
Model 9100 PFT/DICO
2
Cleared 510(K)
K
20
2754
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
2
Cleared 510(K)
K
19
0800
Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
2
Cleared 510(K)
K
18
1912
Ascent Cardiorespiratory Diagnostic Software
2
Cleared 510(K)
K
17
3937
SpiroSphere
2
Cleared 510(K)
K
16
1534
EasyOne Pro Respiratory Analysis System
2
Cleared 510(K)
K
15
0888
Shape-HF Cardiopulmonary Testing System
2
Cleared 510(K)
K
12
2699
SENTRYSUITE PRODUCT LINE
2
Cleared 510(K)
K
12
0635
EASYONE PRO RESPIRATORY TESTING DEVICE
2
Cleared 510(K)
K
11
3813
SENTRYSUITE PRODUCT LINE
2
Cleared 510(K)
K
11
1053
SENTRYSUITE PRODUCT LINE
2
Cleared 510(K)
K
09
1428
EASYONE PRO RESPIRATORY ANALYSIS SYSTEM
2
Cleared 510(K)
K
09
0722
SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
2
Cleared 510(K)
K
08
2539
MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
2
Cleared 510(K)
K
08
0510
VIP PULMONARY FUNCTION SYSTEM
2
Cleared 510(K)
K
08
0734
FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
2
Cleared 510(K)
K
07
1753
MASTERSCREEN PNEUMO & MASTERSCOPE
2
Cleared 510(K)
K
06
2011
MODIFICATION TO FLOWSCREEN
2
Cleared 510(K)
K
04
0549
COSMED PONY FX
2
Cleared 510(K)
K
03
1194
SPIROSOFT
2
Cleared 510(K)
K
02
0745
COSMED MICROQUARK
2
Cleared 510(K)
K
99
3641
METALYZER, MODEL 2; METALYZER, MODEL 3
2
Cleared 510(K)
K
00
0648
SPIRO PRO
2
Cleared 510(K)
K
98
1366
STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES
2
Cleared 510(K)
K
98
0094
MODIFICATION TO THE OXYCONALPHA
2
Cleared 510(K)
K
96
1252
DSXL DIFFUSION SPIROMETER
2
Cleared 510(K)
K
94
2230
OXYCON-ALPHA
2
Cleared 510(K)
K
94
2211
VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
2
Cleared 510(K)
K
93
3839
MASTER SCREEN PNUEMO
2
Cleared 510(K)
K
93
2744
FLOWSCREEN
2
Cleared 510(K)
K
93
3511
UPGRADED SPIROMETER ST-90
2
Cleared 510(K)
K
93
2278
PFM PROFESSIONAL 7000 SPIROMETER
2
Cleared 510(K)
K
92
1309
MODEL 508 PATIENT MONITOR
2
Cleared 510(K)
K
93
0085
VITALOGRAPH DATA STORAGE SPIROMETER
2
Cleared 510(K)
K
91
1358
CMD/DLCO DIAGNOSTIC SPIROMETER
2
Cleared 510(K)
K
89
2705
EBS2605 INFANT HUGGER
2
Cleared 510(K)
K
89
4667
MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP
2
Cleared 510(K)
K
88
3008
PULMONARY FORCED FLOW SYSTEM (PUFFS)
2
Cleared 510(K)
K
88
1122
UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG.
2
Cleared 510(K)
K
86
4836
L.A.P. SPIROMETER
2
Cleared 510(K)
K
86
4087
PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM
2
Cleared 510(K)
K
86
3087
SPIROLOOP-PULMONARY EXERCISE SYSTEM
2
Cleared 510(K)
K
86
1487
ST-90 SPIRO ANALIZER
2
Cleared 510(K)
K
86
1486
SPIROMETRY MODULE
2
Cleared 510(K)
K
85
5068
SPIROMETER, MODEL TS-500 PART #SLZ7534
2
Cleared 510(K)
K
85
5069
SPIROMETER TS-400 SLZ 7547
2
Cleared 510(K)
K
85
4745
CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM
2
Cleared 510(K)
K
85
3433
ELF
2
Cleared 510(K)
K
85
0045
SPIROMETRICS 2453 & SMI III
2
Cleared 510(K)
K
82
3771
SPIROTECH 300
2
Cleared 510(K)
K
82
3683
VITALOGRAPH PFT PRINTER
2
Cleared 510(K)
K
82
1712
INFORMED REMOTE FIELD UNIT MODEL IFM1000
2
Cleared 510(K)
K
81
2850
PTT-200 PULMONARY RECEIVER/MICROPROCES
2
Cleared 510(K)
K
81
2849
PTT-200 TELEPHONIC PULMONARY TRANSMITT
2
Cleared 510(K)
K
81
2792
PFT SCREENER (SYSTEM 1100)
2
Cleared 510(K)
K
81
0712
ELECTRONIC SPIROMETER MODEL MFR-8100
2
Cleared 510(K)
K
80
3053
APEXLINE OF PULMONARY FUNCT. INSTRUM.
2
Cleared 510(K)
K
79
0579
MEDISTOR II
2
Cleared 510(K)
K
78
0584
PULMONARY FUNCTION TESTER
2
Cleared 510(K)
BXA
Analyzer, Gas, Water Vapor, Gaseous-Phase
1
Product Code
BXL
Algesimeter, Manual
1
Product Code
BXQ
Rhinoanemometer (Measurement Of Nasal Decongestion)
2
Product Code
BXR
Meter, Airway Pressure (Inspiratory Force)
2
Product Code
BXW
Calibrator, Volume, Gas
1
Product Code
BZC
Calculator, Pulmonary Function Data
2
Product Code
BZG
Spirometer, Diagnostic
2
Product Code
BZH
Meter, Peak Flow, Spirometry
2
Product Code
BZK
Spirometer, Monitoring (W/Wo Alarm)
2
Product Code
BZL
Computer, Oxygen-Uptake
2
Product Code
BZM
Calculator, Pulmonary Function Interpretor (Diagnostic)
2
Product Code
BZS
Stethoscope Head
1
Product Code
BZT
Stethoscope, Esophageal, With Electrical Conductors
2
Product Code
BZW
Stethoscope, Esophageal
1
Product Code
CBQ
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
2
Product Code
CBR
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
2
Product Code
CBS
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
2
Product Code
CBT
Arterial Blood Sampling Kit
1
Product Code
CBZ
Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
2
Product Code
CCC
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
2
Product Code
CCE
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
2
Product Code
CCI
Analyzer, Gas, Nitrogen, Gaseous-Phase
2
Product Code
CCJ
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
2
Product Code
CCK
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
2
Product Code
CCL
Analyzer, Gas, Oxygen, Gaseous-Phase
2
Product Code
CCM
Plethysmograph, Pressure
2
Product Code
JED
Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling
3
Product Code
JEF
Analyzer, Gas, Neon, Gaseous-Phase
2
Product Code
JEG
Analyzer, Gas, Argon, Gaseous-Phase
2
Product Code
JEH
Plethysmograph, Volume
2
Product Code
JFE
Valve, Switching (Ploss)
1
Product Code
KGK
Gas, Collecting Vessel
1
Product Code
NHO
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
2
Product Code
NHP
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
2
Product Code
NHQ
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
2
Product Code
OFZ
Blood Specimen Collection Kit (Excludes Hiv Testing)
1
Product Code
PNV
Impedance Measuring Device Utilizing Oscillation Techniques
2
Product Code
OGK
Orotracheal Intubation Guide Kit
2
Product Code
PHZ
Abnormal Breath Sound Device
2
Product Code
QEB
Ventilatory Electrical Impedance Tomograph
2
Product Code
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
AN
/
subpart-b—diagnostic-devices
/
BTY
/
K823771
View Source
SPIROTECH 300
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K823771
510(k) Type
Traditional
Applicant
SPIROTECH, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/28/1983
Days to Decision
45 days
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
BSE
Analyzer, Gas, Helium, Gaseous-Phase
BSI
Algesimeter, Powered
BTY
Calculator, Predicted Values, Pulmonary Function
K
22
3629
SpiroSphere, SpiroSphereECG, CardioSphere
K
23
1561
Pulmonary Function Tester, Model: A9
K
22
2982
Virtus Metabolic Monitor
K
22
1030
Model 9100 PFT/DICO
K
20
2754
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
K
19
0800
Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
K
18
1912
Ascent Cardiorespiratory Diagnostic Software
K
17
3937
SpiroSphere
K
16
1534
EasyOne Pro Respiratory Analysis System
K
15
0888
Shape-HF Cardiopulmonary Testing System
K
12
2699
SENTRYSUITE PRODUCT LINE
K
12
0635
EASYONE PRO RESPIRATORY TESTING DEVICE
K
11
3813
SENTRYSUITE PRODUCT LINE
K
11
1053
SENTRYSUITE PRODUCT LINE
K
09
1428
EASYONE PRO RESPIRATORY ANALYSIS SYSTEM
K
09
0722
SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
K
08
2539
MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
K
08
0510
VIP PULMONARY FUNCTION SYSTEM
K
08
0734
FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
K
07
1753
MASTERSCREEN PNEUMO & MASTERSCOPE
K
06
2011
MODIFICATION TO FLOWSCREEN
K
04
0549
COSMED PONY FX
K
03
1194
SPIROSOFT
K
02
0745
COSMED MICROQUARK
K
99
3641
METALYZER, MODEL 2; METALYZER, MODEL 3
K
00
0648
SPIRO PRO
K
98
1366
STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES
K
98
0094
MODIFICATION TO THE OXYCONALPHA
K
96
1252
DSXL DIFFUSION SPIROMETER
K
94
2230
OXYCON-ALPHA
K
94
2211
VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
K
93
3839
MASTER SCREEN PNUEMO
K
93
2744
FLOWSCREEN
K
93
3511
UPGRADED SPIROMETER ST-90
K
93
2278
PFM PROFESSIONAL 7000 SPIROMETER
K
92
1309
MODEL 508 PATIENT MONITOR
K
93
0085
VITALOGRAPH DATA STORAGE SPIROMETER
K
91
1358
CMD/DLCO DIAGNOSTIC SPIROMETER
K
89
2705
EBS2605 INFANT HUGGER
K
89
4667
MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP
K
88
3008
PULMONARY FORCED FLOW SYSTEM (PUFFS)
K
88
1122
UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG.
K
86
4836
L.A.P. SPIROMETER
K
86
4087
PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM
K
86
3087
SPIROLOOP-PULMONARY EXERCISE SYSTEM
K
86
1487
ST-90 SPIRO ANALIZER
K
86
1486
SPIROMETRY MODULE
K
85
5068
SPIROMETER, MODEL TS-500 PART #SLZ7534
K
85
5069
SPIROMETER TS-400 SLZ 7547
K
85
4745
CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM
K
85
3433
ELF
K
85
0045
SPIROMETRICS 2453 & SMI III
K
82
3771
SPIROTECH 300
K
82
3683
VITALOGRAPH PFT PRINTER
K
82
1712
INFORMED REMOTE FIELD UNIT MODEL IFM1000
K
81
2850
PTT-200 PULMONARY RECEIVER/MICROPROCES
K
81
2849
PTT-200 TELEPHONIC PULMONARY TRANSMITT
K
81
2792
PFT SCREENER (SYSTEM 1100)
K
81
0712
ELECTRONIC SPIROMETER MODEL MFR-8100
K
80
3053
APEXLINE OF PULMONARY FUNCT. INSTRUM.
K
79
0579
MEDISTOR II
K
78
0584
PULMONARY FUNCTION TESTER
BXA
Analyzer, Gas, Water Vapor, Gaseous-Phase
BXL
Algesimeter, Manual
BXQ
Rhinoanemometer (Measurement Of Nasal Decongestion)
BXR
Meter, Airway Pressure (Inspiratory Force)
BXW
Calibrator, Volume, Gas
BZC
Calculator, Pulmonary Function Data
BZG
Spirometer, Diagnostic
BZH
Meter, Peak Flow, Spirometry
BZK
Spirometer, Monitoring (W/Wo Alarm)
BZL
Computer, Oxygen-Uptake
BZM
Calculator, Pulmonary Function Interpretor (Diagnostic)
BZS
Stethoscope Head
BZT
Stethoscope, Esophageal, With Electrical Conductors
BZW
Stethoscope, Esophageal
CBQ
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
CBR
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
CBS
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
CBT
Arterial Blood Sampling Kit
CBZ
Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
CCC
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
CCE
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
CCI
Analyzer, Gas, Nitrogen, Gaseous-Phase
CCJ
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
CCK
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CCL
Analyzer, Gas, Oxygen, Gaseous-Phase
CCM
Plethysmograph, Pressure
JED
Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling
JEF
Analyzer, Gas, Neon, Gaseous-Phase
JEG
Analyzer, Gas, Argon, Gaseous-Phase
JEH
Plethysmograph, Volume
JFE
Valve, Switching (Ploss)
KGK
Gas, Collecting Vessel
NHO
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
NHP
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
NHQ
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
OFZ
Blood Specimen Collection Kit (Excludes Hiv Testing)
PNV
Impedance Measuring Device Utilizing Oscillation Techniques
OGK
Orotracheal Intubation Guide Kit
PHZ
Abnormal Breath Sound Device
QEB
Ventilatory Electrical Impedance Tomograph
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
subpart-b—diagnostic-devices
/
BTY
/
K823771
View Source
SPIROTECH 300
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K823771
510(k) Type
Traditional
Applicant
SPIROTECH, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/28/1983
Days to Decision
45 days